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CompletedNCT00663585Updated Jul 29, 2016

Intensive Meditation and Migraines: Effects on Health and Well Being

An interventional study of Vipassana Meditation in Chronic Daily Headache, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-07-29.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Participants completing training in intensive meditation and continuing frequent practice for one year would experience reduced frequency, duration and severity of headaches along with improved awareness of the triggers of their symptoms, improved quality of life and mental health, improved heart rate variability, and reduced inflammation.

02

Conditions studied

  • Chronic Daily Headache

Keywords

  • Migraine
  • Headache
  • Vipassana
  • Meditation
  • Intensive
03

In context

Headache Disorders

169 studies on the registry are indexed under Headache Disorders; 41 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 108 interventional studies indexed under Headache Disorders.

Browse Headache Disorders studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Browse Johns Hopkins University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Chronic Daily Headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines.

Exclusion Criteria:1.

  • Severe depression, anxiety, panic attacks, psychosis or dementia that may interfere with ability to participate in a 10 day course
  • Active alcoholism on screening or use of illicit drugs within the last 3 months
  • Already completed a 10 day course
  • Actively involved in another form of meditation over the past 6 months
  • Women who are pregnant, planning pregnancy during trial period, or lactating.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    1

    Structured Intervention Group

    Behavioral: Vipassana Meditation

  • Active comparator
    2.Comparison group

    Unstructured comparison group

    Behavioral: Vipassana Meditation

Interventions

  • BehavioralVipassana Meditation

    12 day retreat where participants learn to meditate

06

What researchers measure

Primary outcomes

  1. number of migraine days, number of headache days

    Time frame: 3,6,12 months

Secondary outcomes

  1. severity of headaches

    Time frame: 3,6,12 months

  2. quality of life

    Time frame: 3,6,12 months

  3. Heart Rate Variability

    Time frame: 3,6,12 months

07

Study locations

1 site
  • Johns Hopkins School of Medicine
    Baltimore, Maryland 21287, United States
08

References and documents

Publications

  • Goyal M, Haythornthwaite JA, Jain S, Peterlin BL, Mehrotra M, Levine D, Rosenberg JD, Minges M, Seminowicz DA, Ford DE. Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial. Mindfulness (N Y). 2023 Feb;14(2):406-417. doi: 10.1007/s12671-023-02073-z. Epub 2023 Jan 24. PubMed 38282695 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00663585
Lead sponsor
Johns Hopkins University
Responsible party
Madhav Goyal (Assistant Professor, Johns Hopkins University) — Principal investigator
First posted
Apr 22, 2008
Start date
Apr 2008
Primary completion
Feb 2014
Completion
Jun 2014
Last update
Jul 29, 2016

Study contacts

Madhav Goyal, MD, MPH
study director · Johns Hopkins University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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